Achieving hemostasis may be critical to the success of an invasive vascular procedure, such as a diagnostic or therapeutic procedure involving an introduced sheath. In the past, hemostasis has been achieved by manually applying pressure. For example, following cardiac catheterization, a practitioner would press a hand or fingertips to a patient's groin, over an arteriotomy site in the femoral artery. Pressure to the skin would be manually maintained for a period of time (sometimes up to 45 minutes) sufficient to allow the arterial wall to recoil and prevent bleeding from the arteriotomy site.
Advances in arterial compression include hemostatic pressure belts, such as that described in U.S. Pat. No. 5,433,724. The compressive belt detailed therein is positioned around a patient, with a fluid reservoir pouch over an arterial puncture site. Fluid is then pumped into the pouch to increase pressure at the puncture site, under governance of a pressure gauge.
Further advances in hemostasis include suture-mediated closure, along with various resorbable and non-resorbable closure devices such as collagen plugs, gelatin sponges and oxidized cellulose, and cotton, rayon and muslin-based hemostats (respectively). For example. U.S. Pat. No. 5,766,206 provides a penetration member that is inserted through an opening in the skin and an underlying vessel. As the penetration member is withdrawn from the vessel, a pressure gauge indicates when the distal tip of the penetration member has exited the puncture. A hemostatic pharmacon (e.g., collagen) is then ejected from a reservoir within the device, at the puncture site.
Hemostasis may also be aided by hemostatic agents applied to gauze or other wound dressings. U.S. Pat. No. 6,890,344 describes a closure pad for inducing hemostasis through a combination of pressure and the attraction of negatively-charged blood cells to the puncture site, by means of a cationic substance on the pad.
Although the aforementioned closure devices have generally reduced the time needed to achieve hemostasis, devices such as the hemostatic belt may be difficult to secure to a patient, and may slip from the desired compression site if not carefully applied. Further, such a “hands free” device may inspire false confidence in a busy practitioner, who may be tempted to keep lesser watch on a patient using a belt. All of these factors may result in increased bleeding from an arteriotomy site.
Complications have also arisen due to use of resorbable and non-resorbable hemostatic agents such as the ejected pharmacon. For example, allergic reaction, hematomas, arterio-venous fistula, infection, device deployment failure and pseudoanuerysms have been observed, and both resorbable and nonresorbable hemostatic agents have additionally been reported to cause symptomatic mass lesions, most commonly following intra-abdominal surgery. These masses, e.g., textilomas, may be detected in tomographic and other imaging procedures and mistaken for recurrent tumor. Such complications are sufficiently present that manufacturers of several such agents, e.g., Surgigel and Gelfoam, recommend removal of the material once hemostasis is achieved. Ribalta, T., “Textiloma (Gossypiboma) Mimicking Recurrent Intracranial Tumor,” Archives of Pathology & Laboratory Medicine, July 2004. In addition, resorbable and non-resorbable hemostatic agents are expensive, increasing the cost of invasive vascular procedures to hospitals or clinics and to patients.
Accordingly, in the majority of patients, groin closure is still achieved by manual sheath removal and application of hand or fingertip pressure to the groin area. Gauze and wound dressings impregnated with hemostatic agents may shorten the time period necessary to achieve hemostasis by manual compression; however, manual compression still requires time and effort on behalf of vascular suite personnel, who must learn and carry out effective hemostasis techniques. A practitioner applying manual compression is additionally subject to hand fatigue, especially in complicated cases requiring a greater compression time.